In the first case calling upon a court to interpret and apply Vanessa's Law, the Federal Court has ordered Health Canada to release requested complete copies of all sections of all clinical study reports and all electronic datasets from the clinical trials, including participant level datasets, for GARDASIL, GARDASIL 9, CERVARIS, TAMIFLU and RELENZA: Doshi v Canada (Attorney General), 2018 FC 710.
Vanessa's Law – the Protecting Canadians from Unsafe Drugs Act (Vanessa's Law) – was enacted in 2014 to amend the Food and Drugs Act, including by adding subsection 21.1(3) (see our update article here). The provision permits the Minister of Health to disclose confidential business information about a therapeutic product in certain circumstances.
The applicant, Peter Doshi, filed requests with Health Canada to obtain information pursuant to section 21.1(3). Dr. Doshi proposed to use the information for his academic research.
Health Canada accepted that Dr. Doshi was "a person who carries out functions relating to the protection or promotion of human health or the safety of the public" and that, for one of his proposed research projects, the disclosure would be "related to the protection or promotion of human health or the safety of the public," as required under section 21.1(3). Nevertheless, Health Canada required Dr. Doshi to sign a confidentiality agreement. Dr. Doshi refused and Health Canada denied his request on this basis. Dr. Doshi sought judicial review.
As an initial matter, the Federal Court judge, Grammond J., disagreed with Dr. Doshi that Health Canada can never impose a confidentiality requirement when disclosing clinical data under subsection 21.1(3). Upon analyzing the text, context and scheme of the legislation and its legislative history, the Court noted that Vanessa's Law provides a two-track approach to "confidential business information". Subsection 21.1(3) suggests the government may validly impose a confidentiality requirement with respect to specific categories of information (e.g. trade secrets).
Under the other track, the regulation-making powers of subsubsection 30(1.2), the government has released proposed regulations providing for the publication of clinical information when a decision is made on a new drug submission. Until such regulations are made, subsection 21.1(3) applies. (For an update and links, see article here, reporting Health Canada's release of draft guidance on the implementation of the proposed regulations.)
The judge held that Health Canada's decision was unreasonable. First, the judge found that Health Canada's decision disregards one of the main purposes of Vanessa's Law, namely to improve clinical trial transparency.
Second, the judge found that Health Canada fettered its discretion by adopting a blanket confidentiality policy, when Parliament had declined to stipulate that information disclosed pursuant to subsection 21.1(3) must remain confidential. The proposed regulations recognizing the value of clinical trial transparency made Health Canada's position more untenable.
Third, the judge found that in preventing Dr. Doshi from quoting from the clinical trial reports, the confidentiality requirement would breach his freedom of expression under section 2(b) of the Canadian Charter of Rights and Freedoms. The restriction was without justification given the statutory purpose of improving clinical trial transparency.
The Attorney General of Canada may appeal, as of right.
The preceding is intended as a timely update on Canadian intellectual property and technology law. The content is informational only and does not constitute legal or professional advice. To obtain such advice, please communicate with our offices directly.